Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Pharmacokinetic and Safety Study of SPARC1023 Alone and in Carboplatin Combination

This study has been completed.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited Identifier:
First received: February 23, 2011
Last updated: October 20, 2016
Last verified: October 2016
Phase I study of SPARC1023 alone and in combination with carboplatin

Condition Intervention Phase
Solid Tumor in Advanced Stage
Drug: SPARC1023 I
Drug: SPARC1023 II
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • Determination of MTD [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: Yes ]
    MTD for SPARC1023 in combination with carboplatin will be determined. MTD will be defined as the SPARC1023 dose below the dose at which DLT (Dose Limiting Toxicity) is seen for ≥ 2 subjects.

Secondary Outcome Measures:
  • Establishing the pharmacokinetic profile [ Time Frame: One 21-day treatment cycle ] [ Designated as safety issue: No ]
    Plasma levels of SPARC1023 and Carboplatin will be determined and PK parameters viz. Cmax, AUC0-t, AUC 0-∞, MRT, Tmax, t½ , Kel, Vd for SPARC1023 in combination with carboplatin will be evaluated.

Estimated Enrollment: 30
Study Start Date: October 2011
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARC1023 I Drug: SPARC1023 I
IV administration
Experimental: SPARC1023 II Drug: SPARC1023 II
IV administration

Detailed Description:
Pharmacokinetic profile and dose escalation study of SPARC1023 when administered as 30-min infusion.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥18 years
  • ECOG Performance Status ≤ 1.
  • Estimated life expectancy of at least 12-weeks;
  • Measurable disease as per RECIST guideline (Version 1.1);

Exclusion Criteria:

  • Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia, or in situ cervical cancer
  • Known hypersensitivity to the study drugs
  • Treatment with any anti-cancer agents within 28 days of study entry
  • Presence of clinically evident active CNS metastases, including leptomeningeal involvement, requiring steroid or radiation therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01304303

United States, New York
SPARC Site 1
Buffalo, New York, United States
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited Identifier: NCT01304303     History of Changes
Other Study ID Numbers: CLR_10_23 
Study First Received: February 23, 2011
Last Updated: October 20, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Sun Pharma Advanced Research Company Limited:
platinum processed this record on October 26, 2016